Questions about data manipulation [GxP / QC / QA]

posted by Ohlbe – France, 2024-04-30 20:25 (161 d 13:19 ago) – Posting: # 23971
Views: 5,592

Dear QA,

❝ Is it advisable that CRO use this software (after implementing the SOP within the system)...


Anders will be delighted to do that for them :-)

❝ and prove that no such manipulation was done during BE study.


Well, what you will "prove" is that either:
  1. there was no manipulation, or
  2. the CRO was smart enough to do it in a way that will fool the software, or
  3. they manipulated the study in a totally different manner, which the software cannot detect...
My concern is that by using the software, bad CROs will just learn how not to get caught. You will not uproot cheating, only change the way cheaters operate.

❝ By this way both sponsors and CROs are relaxed and regulatory authority will also have readily available data from the software.


Yes, until someone comes with evidence of 2 or 3.

❝ The idea behind above approach is, there is no other way of finding such manipulation (profile duplication) during routine QA review or monitoring by sponsor.


Agree (especially if, as suggested in some older cases, the sponsor was perfectly aware of what was going on, and even selected the CRO for that exact reason). By the way, remember that profile duplication and trends in the PK data are two sides of the same coin.
—
Regards
Ohlbe

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